Naivex and Tafero EM 12 Months

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BRAND :  NAIVEX-TAFERO-EM-12-MONTH-COURSE PRICE :  1475$ STRENGTH : 50MG ACTIVE :  NAIVEX-TAFEROEM (12 MONTH COURSE) COMPANY NAME :  HETERO TABLETS :  30 TABLETS read more

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Drug profile of Naivex Tafero EM 12 months Tablets

Naivex Tafero EM 12 months tablets are used for treatment involved in HIV-1 infections.

Naivex tablets are containing Dolutegravir as an active component; whereas Tafero EM tablets are containing Tenofovir Alafenamide & Emtricitabine as active ingredients.

Naivex is pharmacologically classified as an integrase inhibitor.

Tafero EM is pharmacologically classified as nucleoside reverse transcriptase inhibitor.

This Naivex Tafero EM combination is approved by FDA, which may provide better activity against HIV-1 infections.

Naivex Tafero EM should not have capability of curing the HIV infection, but it can able to reduce the development of HIV-1 further to AIDS.

This is a fixed dose combination of one Integrase inhibitor with two nucleoside reverse transcriptase inhibitors.

Brand name: Naivex Tafero EM 12 months tablets

Active components: Dolutegravir + Tenofovir Alafenamide & Emtricitabine

Strength: 50mg + 25mg & 200mg respectively

Pack: 30 tablets in a container of both products

Mfg: Hetero

Category: Anti-retroviral drugs

 

Prescribing information of Naivex Tafero EM

The prescribing information of Naivex Tafero EM is used for treating the HIV 1 infection for both adults and pediatric weighing of at least 30kg.

Tafero EM should not be combined with protease inhibitors.

Tafero EM indicated in pediatric patient with weight of at least 25kg & below 35kg.

Drawback occurs in Tafero EM uses;

Tafero EM should not be used in pre exposure prophylaxis therapy to diminish the danger of sexually obtained HIV-1 in grown-ups at high hazard.

Mechanism of Naivex Tafero EM

Naivex- Dolutegravir is a competitive to virus associated to HIV infection.

Dolutegravir is an Integrase strand transferase inhibitor, which is active against HIV type 1 infection. Dolutegravir binds to the active site of integrase enzyme, HIV enzyme that helps to transmit viral genetic material into human chromosomes.

This binding inhibition prevents integrase binding to retro virus DNA and causes blockade of strand transfer step which is required for cell proliferation process.

Naivex helps to prevent the HIV type 1 cell production.

TAF is manufactured as prodrug, which is conversed into active form inside the body known as tenofovir. TAF containing cell permeability activities, through this effect it get penetrate into the infected cells and changed over as tenofovir.

Inside the cells, tenofovir is phosphorylated into tenofovir diphosphate by hydrolysis.

Tenofovir diphosphate shown anti-retroviral activity by intercedes into viral DNA and causes inhibition of chain formation leads to stopping the viral production.

Emtricitabine into Emtricitabine 5’ triphosphate, this conversion occurs inside the body and causes chain eliminator effect by struggling with deoxycytidine 5’triphosphate.

Absorption

After administration, the maximum plasma concentration of Tafero EM;

TAF within 60 minutes; Emtricitabine occurs within 3 hours

Dolutegravir reaches within 2 to 3 hours.

The steady state level of Dolutegravir occurs within 5 days

The blood plasma ratio of Tafero EM;

TAF: 1.0; Emtricitabine: 0.6

Distribution

Binding property of TAF to human plasma protein by 80%; Emtricitabine to <4%

Dolutegravir is broadly binds to proteins by 98.9%.

Metabolism

The metabolism of Dolutegravir is majorly occurs with the aid of UTG1A1 with lesser range of CYP3A

The metabolism of TAF is occurs through cathepsin A, carboxyl esterase 1

Emtricitabine undergoes biotransformation.

Excretion

The major metabolism of Tafero EM is occurs through kidneys.

70% of Emtricitabine dose occurs via urine; 13.7% via feces.

<1% of TAF dose eliminated via urine; 31.7% eliminated via feces.

The elimination route of Dolutegravir is majorly occurs in urine, feces.

The half life period of Naivex is 14 hours

The half life period of Tafero EM is;

TAF: 0.51 hour; Emtricitabine 10 hours

When to take the Naivex Tafero EM

Both Naivex Tafero EM tablets should be administered with or without food.

Before taking the Tafero EM tablet, patient must be examine for hepatitis B infection.

Renal function test should be followed.

Dosage regimens of Naivex Tafero EM

The prescribed dose of Tafero EM is one tablet should be administered as a single dose.

Tafero EM is applicable for adults, pediatric with body weight at least 25 kg or below 35kg, or creatinine clearance higher or equal to 30ml/min.

Tafero EM should not be used in patient with CrCl below 30ml/min.

The dosage of Naivex tablets;

For adults;

Therapy naïve or therapy experienced INSTI:

The dose of Naivex is 50mg should be administered orally as once a day.

Therapy naïve or therapy experienced by combining with UGT1A or CYP3A:

The dose of Naivex is 50mg should be administered orally as two times a day.

INSTI experienced with INSTI related resistance:

The dose of Naivex is 50mg should be administered orally as two times a day.

For pediatrics;

The potency of Naivex is applicable only for patient with weight of at least 30kg.

30 to less than 40kg: 35mg of Naivex tablet should be given as once a day

(One 25 mg tablet + one 10 mg tablet).

40kg or higher: 50mg Naivex is administered as once a day

Naivex Tafero EM caused side effects

Naivex associated side effects;

Hypersensitivity reactions

Liver toxicity

Immune reconstitution syndrome

Insomnia

Depression

Abnormal dreams

Dizziness

Headache

Diarrhea

Nausea

Rash

Fatigue

Vertigo

Elevation of;

AST, ALT

Bilirubin

Creatine kinase

Blood glucose

Lipase

Post marketing effects;

Acute liver damage, liver toxicity

Arthralgia

Myalgia

Anxiety

Tafero EM associated side effects;

Aggravation of hepatitis B

Immune reconstitution syndrome

Outbreak or severity of renal impairment

Lactic acidosis or hepatic steatosis

 Loss of bone mineral density

Laboratory abnormality

Virological response alteration

Drug- drug interaction

1. TAF is a component of Tafero EM which is considered as substrate of P-gp, BCRP, OATP1B1, & OATP1B3.

2. Tafero EM co administered with strong P-gp or BCRP inhibitors leads to cause variation in TAF absorption.

3. Tafero EM co administered with P-gp inducers leads to cause depleting the absorption of TAF concludes as decreasing in plasma concentration of TAF and loss of effectiveness of Tafero EM.

4. Co administration of Tafero EM with drugs that inhibits the P-gp or BCRP leads to cause elevates the absorption & plasma concentration of TAF.

5. Tafero EM is majorly eliminated via kidneys. Tafero EM combined with drugs which affect the kidney functions causes increasing the concentration of component in Tafero EM and causes increasing the risk effects of Tafero EM.

6. Tafero EM with protease inhibitors causes decreasing the effect of concentration of TAF.

Tafero EM combines with anti-convulsants agent, anti-mycobacterials, or st Johns wort leads to produce decreasing effect of concentration of TAF.

7. Naivex elevates the plasma concentration of drugs which excreted through OCT2 or MATE1.

8. Etravirine diminishes the plasma concentration of Dolutegravir.

9. Naivex combined with efavirenz causes decrease the effect of concentration of Dolutegravir.

10. Naivex combined with protease enzymes leads to cause decreasing the effect of concentration of Dolutegravir.

11. Co administration of Naivex with dofetilide causes increasing concentration of dofetilide.

Naivex combined with anti-convulsants causing depletion of effect of concentration of Dolutegravir.

11. Naivex combined with calcium or iron containing supplements causes decreasing the effect of concentration of Dolutegravir.

12. Naivex combined with metformin, causes elevation of metformin concentration.

13. Naivex with rifampin produces depletion of Dolutegravir concentration.

Food drug interaction

Minor food drug interaction is occur

Diet should be followed by the patients after getting advice from the physician.

Possible contraindications

Hypersensitivity reactions produces, if patients are contraindicate to the component present in both Naivex & Tafero EM.

Co administration of Naivex & dofetilide or metformin is contraindicated because this combination leads to cause increasing the concentration of dofetilide or metformin. This may concludes as life threatening conditions.

Safety measures

During the treatment with Naivex Tafero EM some life threatening conditions may produce. Some safety precautions should be taken during or after completion of treatment.

1. An anaphylactic reaction occurs like rashes, sometimes organ dysfunction also occurs.

In this condition, patient may provide with general supportive measures and monitoring the liver enzymes level periodically.

In severe condition therapy should be discontinued.

2. Liver toxicity: This condition occurs due to increased serum AST & ALT levels.

Hepatic function test should be performed regularly and maintained the levels of hepatic enzymes.

In severe condition, therapy should be stopped.

3. Exposure of adverse reactions due to drug interactions; some drugs may reduce the plasma concentration of both the products and leads to loss the activity.

Avoid this type of concomitant treatment.

4. Immune reconstitution syndrome, this condition only occurred in the patients who are receiving anti-retroviral therapy. In severe condition patient should be discontinued with the treatment.

5. Severe aggravation of hepatitis B infection occurred in the patient receiving Tafero EM. The potency of Tafero EM in chronic hepatitis B infection has not been evaluated.

To overcome the problem patient should be treated with anti-hepatitis B drugs.

6. Renal impairment should be in severe condition in case of combining Tafero EM with drugs affecting the kidney functions. To avoid the problem kidney function test should be performed.

Patients, who are having creatinine clearance level below 30ml/min, should not be taking anti-retroviral medicines.

7. Lactic acidosis or hepatic steatosis; the major risk factor occurs during this condition is obesity. In severe condition stop the treatment.

Pregnancy and lactation

Pregnancy category of Tafero EM is B; Naivex is B

Naivex Tafero EM uses in pregnancy condition as cautiously. Counsel the patients about the risk benefits before starting the treatment with Naivex Tafero EM.

Breast feeding should not be allowed.

Storage and handling

Naivex container should be stores at 25oC; Tafero EM should be stored below 30oC.

Protect from light

Keep away from moisture & heat

Missed dose

In case of missed dose, patient must be consult with physician and follow the regular dosing schedule.

Over dosage

In case of over dosage of Naivex Tafero EM, patient should be;

Provide with general supportive management

The manifestation of over dosage should be monitored.

Naivex is crucial to remove through dialysis, because it is largely bound to human plasma protein.

Tafero EM should be removed by undergoing hemodialysis.

30% of Emtricitabine dose should be eliminated after 3 hours of hemodialysis.

54% of tenofovir content should be removed over the period of 4 hours of dialysis session.

 

 

Valcivir - Valacyclovir

Product index of Valcivir

Brand name: Valcivir

Active substance: valacyclovir

Strength: 500mg, 1000mg

Mfg: Cipla

Pack: 3 tablets in a carton

Category: Anti-viral drug

Description of Valcivir

Valcivir contains an active ingredient like valacyclovir which is pharmacologically categorized as nucleoside analogue of viral DNA polymerase prohibitor.

Valacyclovir is synthetically classified as nucleoside analogue.

Valacyclovir is generally present as prodrug which gets converted into an active moiety known as acyclovir.

Pharmacology of Valcivir

Valacyclovir is a prodrug which is undergoing phosphorylation by using viral thymidine kinase enzyme for conversion of acyclovir triphosphate, an active metabolite.

This active moiety is involved in the inhibition of herpes viral DNA multiplication by competitive prohibition of viral DNA polymerase.

After insertion of this metabolite into the virus & leads to terminate the growing viral DNA chain.

Valacyclovir involves in;

Stop the DNA synthesis

Destabilizing the strand

Inhibition of new viral growth

Pharmacokinetics of Valcivir

Absorption

After oral intake of Valcivir, valacyclovir is quickly absorbed from the gastrointestinal tract and reaches oral bioavailability by 54.5% plus or minus 9.1%.

Distribution

After absorption occurs, the human plasma protein binding capacity is occurs by 13 to 18%.

Metabolism

Valacyclovir is quickly absorbed and approximately 99% of drug get converted into an active form like acyclovir & L-valine by undergoing first pass metabolism & hepatic metabolism by enzymatic hydrolysis.

Elimination

Nearly 89% of radioactivity gets eliminated via urine.

The median half life period of valacyclovir is occurs in 2.5 to 3.3 hours.

Indication of Valcivir

The primary indication of valacyclovir is used in the condition like;

Herpes simplex & herpes zoster

In adults;

Valcivir is majorly indicated for the therapy of cold sores by Herpes Labialis.

Valcivir potency started after the advancement of clinical signs of cold sore has not been evaluated.

Valcivir is also indicated in the condition like initial episode of genital herpes in immuno competent adults.

Valcivir is also used in the therapy of recurrent episodes of genital herpes in immuno competent episodes.

Valcivir is demonstrated for cutting edge suppressive treatment of repetitive scenes of genital herpes in immuno skillful and HIV-1 contaminated grown-ups.

Valcivir is also indicated for the reduction of transmission of genital herpes in immuno competent adults.

Valcivir is used in the therapy of herpes zoster in immuno competent adults.

In pediatrics;

In pediatric patients, Valcivir is involved in the treatment of cold sores with the age of greater or equal to 12 years.

Valcivir is also indicated for the therapy of chicken pox in immuno competent pediatric patients with age of 2 to less than 18 years.

The major drawback of Valcivir;

The potency of valacyclovir has not been established in;

Patients with age of less than 12 years with cold sores

Patients with age of less than 2 years or greater than or equal to 18 years with chicken pox.

Patients with the age of less than 18 years with genital herpes

Patients with age of less than 18 years with herpes zoster

Not indicated for neonates & infants as suppressive treatment.

Dosage & Administration of Valcivir

Valcivir tablet should be administered with or without food.

In adults;

Cold sore (herpes labialis): The prescribed dose of Valcivir is 2 gram should be taken for two times a day for one day in 12 hours apart.

Genital herpes (initial episode): The prescribed dose of Valcivir is 1 grams should be taken as twice daily for 10 days.

Recurrent episode: The prescribed dose is 500mg should be administered orally as twice daily for 3 days.

Suppressive treatment: In ceaseless suppressive treatment, the recommended measurements is 1 gram taken as once every day in patients with typical capacities. In patients with 9 repeats for every year, the recommended dosage is 500mg ought to be regulated as once day by day.

In HIV-1 infected patients: 500mg of Valcivir should be administered orally as two times a day.

Reduction of transmission: 500mg of Valcivir should be taken as once daily.

Herpes zoster: In this condition, the recommended dose of Valcivir is 1gm should be taen as three times a Day for 7 days.

In pediatrics;

Cold sores (herpes labialis): The patient’s age of greater or equal to 12 years, the recommended dose of Valcivir is 2 gram should be taken as twice daily for 1 day.

Chicken pox: 20mg/kg of Valcivir should be administered orally as three times a day for 5 days.

The maximum dose per day is not exceeding 1 gram 3times a day.

Side effects of Valcivir

The major adverse effects of Valcivir are;

Thrombotic thrombocytopenia purpura/hemolytic uremic syndrome

Acute renal failure

Central nervous effects

The common side effects;

Anemia

Increased AST

Neutropenia

Respiratory tract infection

Decreased platelet counts

Nasopharyngitis

Headache

Dizziness

Nausea

Abdominal pain

Post marketing effects;

Facial edema

Hypertension

Tachycardia

Anaphylactic reactions

CNS disorders

Visual abnormalities

Liver enzyme abnormality

Hepatitis

Renal failure

Aplastic anemia

Erythema multiforme

Alopecia

Contraindications of Valcivir

Valcivir is highly contraindicated in patients with hypersensitivity reactions due to patients are contraindicated to the ingredients of Valcivir.

Drug interactions of Valcivir

No drug- drug interactions occurs in the valacyclovir therapy./

Warning & precautions

Thrombocytopenia:

This condition occurs during the therapy using with Valcivir, this may leads to death with chronic HIV-1 disease & bone marrow transplant.

In this fatal condition treatment should be immediately stopped & monitor the manifestation due to this lethal case.

Acute renal failure;

Use Valcivir in geriatric patients very carefully.

Dosage reduction should be recommended for renal impaired patients.

Patients who are receiving nephrotoxic drugs should be taken caution while getting Valcivir tablets.

Patients have no sufficient hydration may leads to precipitation of acyclovir in renal tubules.

Central nervous system effects;

In pediatric patients with or without renal impairment should be identified with nervous problems like agitation, hallucination, confusion, seizures during the treatment with Valcivir.

In this condition therapy should be stopped.

Pregnancy & lactation

The pregnancy category of valacyclovir is B

It should be used with caution.

Caution should be taken while administering Valcivir to nursing woman.

Storage

Valcivir should be stored at temperature of 15oC to 25oC.

Keep away from moisture, heat & light.

Missed dose

Missed dose condition should be avoided by maintain the regular dosing schedule.

Do not skip the dose.

In case of missed dose condition, patient should be get advice from the medical practitioner & follow the instructions.

Avoid self medication.

 

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